ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID (ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID).
Zinc sulfate heptahydrate: Cofactor for numerous enzymes, essential for DNA synthesis, cell division, and immune function. Cupric sulfate: Component of cytochrome c oxidase and superoxide dismutase, involved in iron metabolism and antioxidant defense. Manganese sulfate: Cofactor for arginase, superoxide dismutase, and other enzymes; involved in bone formation and glucose metabolism. Selenious acid: Incorporated into selenoproteins (e.g., glutathione peroxidases) that protect against oxidative damage.
| Metabolism | Zinc: Excreted primarily in feces; minimal hepatic metabolism. Copper: Excreted mainly via bile; some metabolism by superoxide dismutase. Manganese: Excreted via bile; no significant metabolism. Selenium: Metabolized to selenide, then methylated to selenoamino acids and excreted in urine. |
| Excretion | Zinc: ~90% fecal (via pancreatic and biliary secretions), ~10% renal; Copper: ~80% biliary/fecal, ~20% renal; Manganese: ~98% biliary/fecal, ~2% renal; Selenium: ~60% renal (as selenite/selenate), ~40% fecal (as selenoproteins). |
| Half-life | Zinc: ~6-12 hours (rapid initial phase) with terminal half-life ~2-4 weeks from bone and muscle stores; Copper: ~12-24 hours for plasma, whole body ~5-10 days; Manganese: ~10-42 hours (whole body); Selenium: ~11 days (selenite) to ~66 days (selenoproteins). |
| Protein binding | Zinc: ~98% bound (albumin, α2-macroglobulin, transferrin); Copper: ~90-95% bound (ceruloplasmin, albumin); Manganese: ~80% bound (albumin, β1-globulin, manganese-binding proteins); Selenium: ~50-70% bound (selenoprotein P, albumin, glutathione peroxidase). |
| Volume of Distribution | Zinc: ~0.1-0.3 L/kg (primarily intracellular and bone); Copper: ~0.1-0.2 L/kg (liver, brain); Manganese: ~1-2 L/kg (mitochondria-rich tissues); Selenium: ~0.3-0.6 L/kg (whole body, accumulates in kidney, liver). |
| Bioavailability | Oral: Zinc sulfate ~20-30% (fasted); Copper sulfate ~30-40%; Manganese sulfate ~5-15%; Selenious acid ~50-80% (as selenite). |
| Onset of Action | Oral: Zinc, copper, manganese, selenium: 1-2 weeks for measurable changes in serum levels; IV: Immediate for serum levels, clinical effects (e.g., enzyme function) within days. |
| Duration of Action | Zinc: weeks to months (depends on stores); Copper: weeks; Manganese: weeks; Selenium: weeks to months. Duration reflects replenishment of body stores and normalization of dependent enzymes. |
Adult: 1 mL (containing zinc sulfate heptahydrate 2.5 mg, cupric sulfate 1 mg, manganese sulfate 0.5 mg, selenious acid 60 mcg) added to TPN or IV fluids, administered intravenously once daily.
| Dosage form | INJECTION |
| Renal impairment | Contraindicated in severe renal impairment (GFR <30 mL/min) due to risk of trace element accumulation; for GFR 30-60 mL/min, reduce dose by 50% or monitor serum levels; no adjustment needed for GFR >60 mL/min. |
| Liver impairment | Child-Pugh Class A: No adjustment; Child-Pugh Class B: Reduce dose by 50%; Child-Pugh Class C: Discontinue or use with extreme caution, monitor serum levels. |
| Pediatric use | Children: 0.2 mL/kg/day (not to exceed adult dose) added to TPN or IV fluids, administered intravenously once daily; for preterm infants, 0.15 mL/kg/day. |
| Geriatric use | No specific adjustment required, but monitor renal function due to age-related decline; consider starting at lower end of dosing range and titrate based on serum trace element levels. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID (ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID).
| Breastfeeding | Excreted into breast milk; considered compatible with breastfeeding at recommended doses. M/P ratio not established. |
| Teratogenic Risk | First trimester: No known teratogenicity at recommended doses. Second/third trimester: Essential for fetal development; deficiency may cause congenital malformations. High doses may be toxic. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any component; Wilson disease (copper overload); hemochromatosis (iron overload, but cautious with copper); severe cholestasis or liver failure (risk of manganese accumulation)
| Precautions | Monitor serum trace element levels to avoid toxicity; copper and selenium can accumulate in cholestasis; manganese toxicity risk in liver dysfunction; allergic reactions possible; use with caution in renal impairment. |
Loading safety data…
| Serum zinc, copper, manganese, and selenium levels; maternal symptoms of deficiency or toxicity; fetal growth ultrasound. |
| Fertility Effects | No adverse effects on fertility at recommended doses; deficiency may impair fertility. |